Senior Director, Global Regulatory Affairs Liaison

Senior Director, Global Regulatory Affairs Liaison

Gilead

Dublin, Ireland

As Senior Director, Global Regulatory Affairs Liaison – Pediatric Center of Excellence, you will act as a senior regulatory representative and pediatric subject matter expert to cross-functional leaders and teams. You will play a leadership role on regulatory leadership teams, at the Pediatric Center of Excellence and in ad hoc or special projects/initiatives that seek to continuously improve or advance GRA capabilities.

RESPONSIBILITIES:

• Accountable for oversight and leadership of the development and successful completion of global pediatric regulatory strategies, submissions, documents, activities, and other deliverables for products across the Virology, Oncology and Inflammation TAs to achieve strategic milestones and objectives.
• Makes significant contributions to the ongoing development and optimization of pediatric regulatory strategies, processes, standards, and practices in collaboration across Global TA regulatory liaisons and cross-functional teams to ensure alignment with broader product development goals, driving efficiency and enhancing organizational capabilities.
• Represents Gilead in negotiations with regulatory authorities as needed.
• Proactively identifies regulatory or pediatric-related risks/issues and ensures timely development of mitigation and/or contingency plans.
• Manages one or more direct reports.
• Provides accurate and thorough input and recommendations into resource plans required to complete deliverables. Tracks resources to ensure compliance with agreed resource allocation, including budgets.
• Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
• Provides significant leadership as a member of the Global TA Regulatory Liaison leadership team and leads or contributes to non-program-related corporate/department initiatives, process improvements, best practices, and projects.
• Provides leadership and advisement for Pediatric Center of Excellence site management.

REQUIREMENTS:

Education & Experience

• MA/MS/MBA/PharmD/PhD with 12+ years’ relevant experience.
• BA/BS with 14+ years’ relevant experience.
• Extensive experience in Global Regulatory Affairs (pharmaceutical industry experience is strongly preferred) and developing global pediatric regulatory strategies.
• Experience working with one or more Gilead therapeutic areas and varying stages of drug development is strongly preferred.
• Extensive leadership experience and proven effectiveness through direct people leadership or matrix leadership.
• Extensive experience and significant successes setting and directing the regulatory or related strategy to successful conclusion for multiple products.
• Experience and proven effectiveness negotiating with regulatory authorities.
• Extensive experience leading and influencing cross-functional teams and activities across a broad spectrum of programs, projects and other activities.
• Proven track record of successfully managing large scale, complex, time-sensitive projects.

Knowledge & Skills

• Exceptional interpersonal, self-awareness and negotiation skills, including effective verbal/written communication, team orientation, critical thinking, active listening, problem-solving, dependability, and adaptability, and understanding of team dynamics.
• Expert knowledge of the drug development process, and global and regional regulatory requirements for medicinal products.
• Advanced regulatory and business knowledge and advanced analytical abilities, as evidenced by strengths in assessing complex, multidisciplinary data, and understanding and effectively advising on its regulatory implications.
• Demonstrable ability to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives and steering committees.
• Ability to summarize complex matters into a clear business case and roadmap for execution.
• Strong coaching capabilities to mentor/develop staff.
• When needed, ability to travel.